USP Shift Lead Manufacturing

Work Schedule

Environmental Conditions

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. We strive to support our customers in promoting a healthier, cleaner, and safer global environment. Whether our customers are advancing life sciences research, solving sophisticated analytical challenges, improving efficiency in their laboratories, promoting patient health through diagnostics, or developing and manufacturing life-changing therapies, we are here to assist them. Our distributed team of over 100,000 colleagues collaborates across various locations to provide a ground-breaking mix of brand-new technologies, convenient purchasing options, and pharmaceutical services. Our industry-leading brands include Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

The state-of-the-art multi-purpose manufacturing facility is crafted for large-scale production of biologics and has high expansion potential. After completion of construction activities, our site in Lengnau will offer highly flexible biomanufacturing technologies, from development to large-scale production including stainless steel equipment to meet our customer needs.

Purpose

• This position leads a manufacturing team (shift in upstream, downstream, solution preparation and support) to ensure the operational activities for the production of recombinant products
• This position supports project teams in the design, commissioning, qualification and validation of new production lines for recombinant products
• This position supports New Product Introduction for recombinant products

Responsibilities

• Is responsible for the daily operations of their shift in manufacturing suites, including daily schedule, shift rotations
• Lead and develop team members in order to run areas robustly and smoothly, ensuring appropriate succession planning
• Participates in defining robust process parameters during routine manufacturing campaigns
• Build cross functional teams and work well with other support functions such as Quality Assurance, Quality Control, Manufacturing Science and Tachnology, Engineering, Validation, and other relevant functional areas
• Ensures implementation of and adherence to current GMP rules, Quality policies, procedures and instructions for their area of responsibility.
• Ensures contribution of their interpersonal unit to continuous quality improvement initiatives and deviation reporting and follow-up.
• Ensures implementation of and adherence to EHSS legal requirements, rules, policies, procedures and instructions for their area of responsibility.
• Ensures contribution of their interpersonal unit to EHSS initiatives and issues as well as near miss reporting and follow-up.

Qualifications

• Bachelor/Master in Chemistry / Biochemistry / Biology / Food Science
• 5-7 years successful experience in pharmaceuticals operations in a GMP relevant environment
• The function requires experience in biotech or pharma processes, either in sterile processes, USP, DSP, solution preparation, single use, CIP/SIP processes
• Good knowledge and competence in the field of automated processes
• Experience in leading teams
• Language: English or German
• Shift work is expected
• On-call support